Trial Outcomes & Findings for A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis (NCT NCT04154293)

NCT ID: NCT04154293

Last Updated: 2022-08-25

Results Overview

Number of subjects with Visual Index for Ichthyosis Severity (VIIS) treatment success, defined as 50% or greater decreased in VIIS scaling score

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-08-25

Participant Flow

Participant milestones

Measure	Vehicle Ointment (Control) Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment
Overall Study STARTED	12	11	11
Overall Study Number Who Received at Least 1 Dose	12	11	10
Overall Study COMPLETED	10	8	9
Overall Study NOT COMPLETED	2	3	2

Reasons for withdrawal

Measure	Vehicle Ointment (Control) Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment
Overall Study Withdrawal by Subject	2	3	1
Overall Study Physician Decision	0	0	1

Baseline Characteristics

A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis

Baseline characteristics by cohort

Measure	Vehicle Ointment (Control) n=12 Participants Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% n=11 Participants Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% n=10 Participants Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment	Total n=33 Participants Total of all reporting groups
Age, Continuous	36.8 years STANDARD_DEVIATION 24.6 • n=5 Participants	31.9 years STANDARD_DEVIATION 18.6 • n=7 Participants	34.5 years STANDARD_DEVIATION 19.7 • n=5 Participants	34.5 years STANDARD_DEVIATION 20.7 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	9 participants n=5 Participants	32 participants n=4 Participants
Region of Enrollment Australia	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intention to treat analysis only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID

Number of subjects with Visual Index for Ichthyosis Severity (VIIS) treatment success, defined as 50% or greater decreased in VIIS scaling score

Outcome measures

Measure	Vehicle Ointment (Control) n=12 Participants Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% n=11 Participants Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% n=10 Participants Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment
Number of Subjects With Reduction in Targeted Ichthyosis Severity Using the Visual Index for Ichthyosis Severity Measurement	4 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to treat analysis only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID

Number of subjects with Investigator Global Assessment decrease in disease severity by at least 2 grades

Outcome measures

Measure	Vehicle Ointment (Control) n=12 Participants Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% n=11 Participants Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% n=10 Participants Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment
Number of Subjects With Reduction in Overall Ichthyosis Severity as Measured With Investigator Global Assessment	1 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to treat analysis based upon available data collected. Data imputation was not performed for I-NRS but only for primary endpoint as above

Mean numeric Change from baseline in Itch-Numeric Rating Scale (I-NRS) at Week 12 for entire population. I-NRS is an 11-point visual analogue scale scored based upon 0 being no itch and 10 being worst itch imaginable. Subjects were asked to grade their itch on such a scale at each visit where I-NRS was administered. A 4-point change from baseline is considered clinically significant

Outcome measures

Measure	Vehicle Ointment (Control) n=10 Participants Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% n=9 Participants Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% n=9 Participants Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment
Change in I-NRS (Itch-Numeric Rating Scale) From Baseline at Week 12	-1.7 units on a scale Standard Deviation 2.54	-1.9 units on a scale Standard Deviation 5.3	1.1 units on a scale Standard Deviation 2.64

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to treat analysis based upon available data collected. Data imputation was not performed for DLQI but only for primary endpoint as above

Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 12 in all adult subjects.

The DLQI is validated in all subjects over age 16 years and is a 10-question questionnaire which requests information on how the dermatological condition affects different aspects of their life. Each question is scored on a 0-3 scale (0=no impact, 3=major impact) for a total possible maximal score of 30. Scores over 11 in adults are considered to indicate moderate impairment of quality of life due to the skin disease. A 4-point improvement from baseline is considered clinically significant

Outcome measures

Measure	Vehicle Ointment (Control) n=8 Participants Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% n=6 Participants Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% n=7 Participants Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12	-3.4 units on a scale Standard Deviation 4.72	-3.2 units on a scale Standard Deviation 9.28	-1.3 units on a scale Standard Deviation 3.95

Adverse Events

Vehicle Ointment (Control)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

TMB-001 Ointment, 0.05%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

TMB-001 Ointment, 0.1%

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vehicle Ointment (Control) n=12 participants at risk Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment	TMB-001 Ointment, 0.05% n=11 participants at risk Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment	TMB-001 Ointment, 0.1% n=10 participants at risk Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment
Cardiac disorders palipations	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	9.1% 1/11 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Ear and labyrinth disorders ear pain	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site dermatitis	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	27.3% 3/11 • Number of events 6 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 2 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site discomfort	8.3% 1/12 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site erosion	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	18.2% 2/11 • Number of events 3 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 2 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site erythema	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	27.3% 3/11 • Number of events 4 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	40.0% 4/10 • Number of events 5 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site hypersensitivity	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	20.0% 2/10 • Number of events 2 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site inflammation	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site edema	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site pain	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	18.2% 2/11 • Number of events 3 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	30.0% 3/10 • Number of events 6 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site pruritis	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	27.3% 3/11 • Number of events 5 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	40.0% 4/10 • Number of events 5 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site rash	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	9.1% 1/11 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
General disorders application site warmth	8.3% 1/12 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Infections and infestations acute sinusitis	8.3% 1/12 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Infections and infestations application site folliculitis	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	9.1% 1/11 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Infections and infestations application site pustules	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	9.1% 1/11 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Infections and infestations folliculitis	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	18.2% 2/11 • Number of events 2 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/10 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Injury, poisoning and procedural complications skin abrasion	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Psychiatric disorders insomnia	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Respiratory, thoracic and mediastinal disorders epistaxis	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Skin and subcutaneous tissue disorders night sweats	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Skin and subcutaneous tissue disorders photosensitivity reaction	0.00% 0/12 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	0.00% 0/11 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID	10.0% 1/10 • Number of events 1 • 12 weeks follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID

Additional Information

Alan Mendelsohn, MD

Timber Pharmaceuticals

Phone: 2673004249

Email: amendelsohn@timberpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place